3 min reading time

Rob Packard tells me the three most common ways companies wreck their FDA submissions are:

1. Wrong pathway. They take the wrong pathway. Say, a 510(k) instead of a De Novo.
2. Wrong test. They spend their money on the wrong tests.
3. Ignored advice. They ignore FDA guidance and/or advice.

That’s what this company did.

Well, that was wasteful

“DeviceCo” had a prototype device to treat patients. It was a non-significant risk device, so they got IRB approval and performed limited clinical testing.

Preliminary results were overwhelming. They immediately began benchtop testing for the 510(k) submission they submitted four months later.

FDA identified the device as non-substantially equivalent and requested a De Novo along with human clinical data. They also recommended a draft clinical study protocol as part of a pre-submission request prior to conducting the study.

But DeviceCo reasoned they already had a clinical study protocol approved by an IRB, so they continued instead of waiting for FDA feedback at the pre-submission.

When they submitted the pre-submission request, they already collected two months of data from nearly 100 clinical subjects.

(You know where this is going, right?)

FDA provides email feedback: They have safety concerns and required significant modifications to the clinical study.

Specifically, FDA wants a control group using a sham device, and additional clinical endpoints to address safety concerns about long-term device use.

Practical FDA Strategies to Avoid Stunning Disaster

Fortunately, you subscribe to MedicalDevicesGroup.net and can sidestep all those mistakes.

I’m co-hosting a live call with Rob on October 17 at 11:15 a.m. to discuss “Practical FDA Strategies to Avoid Stunning Disaster.” Come!

 

Click here for PRACTICAL FDA STRATEGIES.If you can’t make the live event, register anyway!
We’ll send you the recording and slides afterward.

Rob recommends:

Rob told me, “I always recommend two things before you do any testing:
1) Verify you identified the correct regulatory pathway; and,
2) Verify your testing plan meets FDA requirements for a submission.”

Our October 17 conversation will share several practical FDA strategies if you might require a De Novo Request with clinical performance data.

I’ve taken care of the rest. You just need to click to register for what’s essentially a few hundred dollars’ worth of free regulatory advice from one the industry’s best.

See you then!

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How To Use Medical Claims Data

But first, Rick Grape and Rebecca Hauck from LexisNexis Risk Solutions will present “How To Use Medical Claims Data to Grow Your Market and Sales Penetration” next week.

It’s free – and you’ll learn how to use claims data (procedures by surgeon, CPT, and ICD code!) to focus your marketing efforts and help you sell more efficiently.

Click here for the CLAIMS DATA webinar.

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Fast Round about Intellectual Property

At 10x, Fast Rounds recognize each guest is an expert – even if we don’t have time to feature each as a speaker.

I guess I knew IP law is different in each country, but not as clearly as I do now. Stephen Carter explained if you want European patent protection you need to file for a European patent or file nationally in the European jurisdictions.

Software is an area of particular interest when it comes to differences between American and European patents. And do you know what impact Brexit will have? Stephen does.

Give a listen:

We’ll have up to 15 companies featured at 10x London in February! (Stephen will be there!) Want to be featured in a Fast Round like the one above?

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Thank you for being part of our Medical Devices Group community!

Please  especially if they’d benefit in any way from the FDA Strategies or claims data webinars.

Make it a great week.

Joe Hage
Founding Principal,
Medical Devices Advisory Group

P.S. How smart is your shirt? Is it this smart? 🤔